Tuesday, November 20, 2007

The Intimidation of Dr. John Buse

The Senate Finance Committee has jurisdiction over Medicare, Medicaid and the FDA. This makes it an important player in health policy and oversight of the health system. While the Committee’s recent report on “The Intimidation of Dr. John Buse and the Diabetes Drug Avandia” is not as dramatic as John Le Carre’s “The Constant Gardner” (or the excellent film version with Ralph Fiennes), it doesn’t miss by much.

The Committee’s investigation was triggered by a June 14, 2007 New England Journal of Medicine article “Effect of [Avandia] on the Risk of Myocardial Infarction and Death from Cardiovascular Causes.” The article sounded an alarm about the manufacturer (GlaxoSmithKline) and the FDA as well as the drug:

“The manufacturer’s public disclosure of summary results for [Avandia] clinical trials is not sufficient to enable a robust assessment of cardiovascular risks. The manufacturer has all the source data for completed clinical trials and should make these data available to an external academic coordinating center for systematic analysis. The FDA also has access to study reports and other clinical-trial data not within the public domain…”

Six weeks after publication of the New England Journal article, Senators Grassley (R) and Baucus (D) wrote a strong letter to the FDA Commissioner expressing concern about suppression of dissent regarding Avandia. In a statement accompanying release of the letter, Senator Baucus said:

“…under Commissioner von Eschenbach’s leadership it seems that drug manufacturers’ interests may be allowed to trump science. Based on our ongoing investigation, it appears that FDA staff who voiced safety concerns about Avandia were removed from the very jobs that are supposed to protect the American public…”

Happily, someone inside the FDA must have been spilling the beans to Committee staffers.

The November report clearly draws on whistle-blower tips as well. It describes in detail how GlaxoSmithKline sought to silence Dr. Buse, currently president of the American Diabetes Association, who in 1999 was the first to raise concern about increased cardiovascular risk from Avandia. This internal email shows how executives at the company reacted:

“Mention was made of John Buse from UNC who apparently has repeatedly and intentionally misrepresented Avandia data from the speaker’s dias in various fora…the sentiment of the SB [what later became GlaxoSmithKline was then SmithKlineBeecham, i.e., “SB”] group was to write him a firm letter that would warn him about doing this again…with the punishment being that we will complain up his academic line…”

It is probably not often that a Senate Committee Report can be described as a "great read." This one can. Here is another juicy quote -- this one from an email from Dr. Buse to Dr. Steven Nissen, first author of the New England Journal article, describing what happened after he expressed his concerns about Avandia and cardiovascular risk:

"Immediately the company's leadership contact[ed] my chairman and a short and ugly set of interchanges occurred over a period of about a week ending in my having to sign some legal document in which I agreed not to discuss this issue further in public...It makes me embarrassed to have caved in several years ago."

The pharmaceutical industry is once again shooting itself in the foot. This sorry story -- so well set forth by the Senate Finance Committee -- puts another nail in the coffin of Pharma's reputation. It won't be long before lawsuits start to emerge, just as has happened with Vioxx. We can only wonder how many billions of dollars will have to go into settlements and fines before the pharmaceutical industry cleans up its act.

The happy part of this story is the role of the Senate Finance Committee and the whistle blowers who helped them do their important work. We owe them thanks!

1 comment:

Anonymous said...

Crime and Punishment: Enough for Corporate Wrongdoing?

Corporate crime should not be a new concept to many. However, it has evolved into more troubling ways- not only in regards to its severity, but the methods of deterrence now being implemented against corporations- involved in the health care industry in particular. So it may be becoming progressively worse for U.S. citizens as a result.
Rather than speak of all corporations, what will be discussed is government health care fraud. Fraud basically is deception with the potential to harm others. In the case of pharma companies, this may include improper promotion and marketing, meaning that such tactics are or may be deceptive misconduct that may be illegal. In addition, there are the crimes of kickbacks and lesser crimes of misbranding products. Probably more methods of wrongdoing as well do in fact exist and happen. Yet the point is that drug companies should not engage in such wrongdoing to enrich their faceless existence with profiting off those who are ill in illegal ways.
How is such conduct discovered? Typically by whistleblowers who worked for the described pharma company, and such people are rare for a number of reasons. The whistleblower then seeks legal agents and files what is called a qui tam false claims act with a district attorney’s office (Boston or Philadelphia, if you want prosecutors to take you seriously). After the case is filed, the whistleblower verbally acknowledges the charges and evidence to the chosen prosecutors and others.
Such cases usually take years for unclear reasons, yet in the past two years, the settlements from such cases has approached 2 billion dollars after investigations ended that took years, which is tax dollars returned to the American public with these settlements.
So, what has been happening once a pharma company is busted. Criminal indictment by the district prosecutor? Hardly, yet appropriate. Usually, the prosecutor’s objective is to dismiss the case, but give the impression that such activities will not be tolerated by our government. So Corporate Integrity Agreements are mandated to the pharma company, but not really taken seriously, as some have more than one of these agreements active still. It’s an invisible ankle bracelet. A pharma company can and have committed equal or worse crimes while under such an agreement. This Agreement is issued after the deferred or non prosecution agreement is sentenced to the law-breaking corporation, which basically is a pre-trial diversion. Essentialy, it’s just parole, which is supported by the DOJ and the administration. The criminals admit wrongdoing, but not guilt. And they pay a settlement in the neighborhood of hundreds of millions of dollars. Not that shocking, if you consider the income of big pharma companies. These agreements are relatively new and partially a result of suggestions from what was known as a Thompson memo, which basically was created by a DOJ guy as commandments for prosecuting corporations and variables to consider when doing so, which ultimately offered responses as to why a greater degree of punishment was not enforced.
We are one of three countries in the world with the most prisoners behind bars, yet those that do similar if not greater harm to others get out of jail free. Double standard, I would say. Is this behavior by our legal system towards corporations an effective deterrent? Most think not. It rather seems like tacit approval of their conduct. And health care fraud may be more damaging than other types in other industries, yet lack of regulation allows such crimes to continue.
Citizens should make the laws in our country. Justice would then finally exist.

“Corporations cannot commit treason, nor be outlawed, nor excommunicated, for they have no souls.”
---- Edward Coke

Dan Abshear